IRB Advisor – February 1, 2008

February 1, 2008

• Cultural differences raise consent issues in multinational research

  While emphasis often is put on the linguistic challenges of consent creating a document that correctly outlines the details of the study in multiple languages there are cultural translation issues as well. What one culture means by "consent," "risk," or even "research" may be very different from how another culture interprets those concepts.

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• Combination of consent documents may improve subjects' understanding

  When trying to explain a complicated clinical trial to participants, which approach is better: a jam-packed standard-issue informed consent document, or a lower reading level, more interactive model? And which would subjects prefer?

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• Protecting uninsured participants in research

  Nearly 47 million Americans lack health insurance, leaving them without regular access to health care and making them a potentially vulnerable population in health care research.

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• Study offers insight into how subjects feel about standard IC language

  IRBs that desire to improve their informed consent (IC) forms might learn a great deal from questions and comments from people reviewing these forms.

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• Institution provides IRB members with thorough, ongoing training/education

  IRB offices no longer can use the trial-by-fire method of new board member training.

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